Navigation Links
FDA to Step Up Inspections of Imported Products
Date:6/20/2011

MONDAY, June 20 (HealthDay News) -- The U.S. Food and Drug Administration announced Monday a new strategy to help ensure the safety and quality of imported drugs and food products.

The plan, which calls for coalitions of international regulators and increased data sharing, was created in response to rapidly rising imports of FDA-regulated products and a complex global supply chain. The strategy is outlined in a special report called the Pathway to Global Product Safety and Quality, the agency said in a news release.

"Global production of FDA-regulated goods has exploded over the past 10 years. In addition to an increase in imported finished products, manufacturers increasingly use imported materials and ingredients in their U.S. production facilities, making the distinction between domestic and imported products obsolete," FDA Commissioner Dr. Margaret A. Hamburg said in the news release. "There has been a perfect storm -- more products, more manufacturers, more countries and more access. A dramatic change in strategy must be implemented."

To protect the health of U.S. consumers, the FDA needs to modify the way it conducts business and to act globally, according to the report. This new approach includes four main elements:

  • The FDA needs to team with counterparts worldwide to create international coalitions of regulators charged with improving and guaranteeing product quality and safety.
  • These coalitions need to develop international information systems and networks and boost their sharing of data and regulatory resources.
  • The FDA must improve its information gathering and analysis capabilities, with an increased emphasis on risk analysis.
  • There will be increased FDA cooperation with industry, public and private groups, and the agency will allocate its resources based on risk.

The FDA said it's also expanding its food-safety efforts under the FDA Food Safety Modernization Act (FSMA). There will be new inspection mandates, including one to inspect more than 19,000 foreign-food facilities by the year 2016.

"FDA-regulated imports have quadrupled since 2000," Hamburg said. "The FDA and our global regulatory partners recognize this new reality and realize we must work proactively and collaboratively to address the challenges we face."

More information

The FDA offers consumer information about a number of products.

-- Robert Preidt

SOURCE: U.S. Food and Drug Adminstration, news release, June 20, 2011


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Potentially Toxic Flame Retardants Found in Baby Products
2. Plastic products leach toxic substances
3. Drugmakers to End Infant Formulas of Products With Acetaminophen
4. U.S. Officials Take Aim at Questionable STD Products
5. Good news for meat lovers: Most ready-to-eat meat products contain very few cancerous compounds
6. LED products billed as eco-friendly contain toxic metals, study finds
7. Wiley-Blackwell announces 102 additional products available through Research4Life
8. FDA Launches Review of Tobacco Products
9. Whole-Fat Dairy Products May Lower Type 2 Diabetes Risk: Study
10. Tecnalia develops environment-friendly and health-friendly pest control products
11. Use of sunless tanning products common in teens, may encourage sun safety in women
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... ... February 10, 2016 , ... As part of its ongoing series of ... Each webinar features a dynamic expert and thoughtful presentation to give attendees a ... facilities. Both events are free to attend, but registration is required. ...
(Date:2/10/2016)... ... February 10, 2016 , ... Emergency rooms provide emergency care to stabilize ... can leave patients with dental emergencies at risk of losing a tooth or their ... care. , Common dental emergencies include:, , Avulsed or ...
(Date:2/10/2016)... ... February 10, 2016 , ... Intalere’s 2016 Executive ... than 200 of the country’s top healthcare executives to share insights on transformational ... of the Forum is the provider-centric perspective, experience, expertise and strategy shared by ...
(Date:2/10/2016)... ... February 10, 2016 , ... ... award winner and inspirational speaker Jan Fox will serve as keynote speaker at ... will provide participants with tools to more effectively communicate with their own organizational ...
(Date:2/10/2016)... ... February 10, 2016 , ... Everseat has joined ... readily available to physicians. The integration will enable Allscripts users to post open ... Everseat’s free mobile app. , The partnership gives Everseat substantial added power to ...
Breaking Medicine News(10 mins):
(Date:2/10/2016)... -- CSI Specialty Group (CSI) expanded its specialty pharmacy ... Pharmacy Podcast. A free, weekly show, the Specialty Pharmacy ... discussion and context amongst specialty pharmacy peers and professionals. ... The Specialty Pharmacy Podcast, hosted by industry leader ... DiMascio, CHE, CMCE, CPC, is available for streaming and/or ...
(Date:2/10/2016)... and SAN DIEGO , Feb. 10, ... global leader in viral gene therapy manufacturing, and Renova™ ... congestive heart failure and other chronic diseases, have entered ... manufacturing process and produce cGMP-grade RT-100 (Ad5.hAC6) Drug Product ... --> --> This relationship ...
(Date:2/10/2016)... -- Urologix, the market leader for in-office minimally invasive ... (BPH), announces new private ownership and is operating as ... industry veteran of more than 20 years, has been ... Plymouth, Minn. The company,s two ... RF Therapy, will continue to be broadly available and ...
Breaking Medicine Technology: